Hizentra 2gm/10ml Inj, 10ml
Overview
What is this medicine?
How to Use This Medicine
To use this medication correctly, follow your doctor's instructions and read all the information provided. This medication is administered as an infusion under the skin over a period of time. If you are self-administering the injection, your doctor or nurse will provide guidance on the proper technique.
Preparation and Administration
Before using this medication, wash your hands thoroughly. Do not shake the solution. If the medication has been stored in the refrigerator, allow it to reach room temperature before use. Do not heat the medication.
Important Safety Precautions
Do not use this medication if the solution appears cloudy, is leaking, or contains particles. Additionally, do not use it if the solution has changed color or has been frozen. Do not mix this medication with any other liquid medications. Avoid injecting into skin that is irritated, bruised, red, infected, hard, or scarred.
Injection Site Rotation
Rotate the injection site as directed by your doctor to minimize the risk of skin irritation.
Disposal of Needles and Supplies
Dispose of used needles and other sharp objects in a designated needle/sharp disposal box. Do not reuse needles or other items. When the box is full, follow local regulations for proper disposal. If you have any questions, consult your doctor or pharmacist.
Storage and Disposal
Follow the storage instructions provided with the medication. Read the package insert for specific guidance. If you have questions about storing this medication, consult your pharmacist.
Missed Dose
If you miss a dose, contact your doctor to determine the best course of action.
Lifestyle & Tips
- Maintain adequate hydration, especially before and during infusions.
- Learn proper self-administration technique from a healthcare professional.
- Rotate injection sites to prevent skin irritation.
- Keep a log of doses, sites, and any reactions.
- Report any unusual or severe side effects to your doctor immediately.
- Avoid live virus vaccines for a period after receiving Hizentra (discuss with your doctor).
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Condition-Specific Dosing:
Pediatric Dosing
Dose Adjustments
Renal Impairment:
Hepatic Impairment:
Pharmacology
Mechanism of Action
Pharmacokinetics
Absorption:
Distribution:
Elimination:
Pharmacodynamics
Safety & Warnings
BLACK BOX WARNING
Side Effects
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical attention immediately:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of kidney problems, including:
+ Inability to pass urine
+ Changes in urine output
+ Blood in the urine
+ Sudden weight gain
Signs of high or low blood pressure, such as:
+ Severe headache or dizziness
+ Passing out
+ Changes in eyesight
Fever, chills, or sore throat
Unexplained bruising or bleeding
Feeling extremely tired or weak
Blue or gray discoloration of the skin, lips, nail beds, fingers, or toes
Seizures
Bloating
Confusion
Swelling
Abnormal heartbeat
Mood changes
Muscle or joint pain
Changes in speech
Changes in eyesight
Shakiness
Excessive sweating
Severe stomach pain
Dark urine or yellow skin and eyes
Severe Lung Problems and Brain Infection
This medication can cause severe lung problems, which can be life-threatening. If you experience any of the following symptoms, contact your doctor right away:
Trouble breathing
Shortness of breath
New or worsening cough
Additionally, this medication may increase the risk of aseptic meningitis, a severe brain infection. If you experience any of the following symptoms, contact your doctor immediately:
Headache
Fever
Chills
Severe stomach upset or vomiting
Stiff neck
Rash
Sensitivity to light
Feeling sleepy or confused
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to contact your doctor if you're concerned about any of the following:
Irritation at the injection site
Dizziness, tiredness, or weakness
Headache
Upset stomach or vomiting
Stomach pain or diarrhea
Back pain
Muscle spasms
Signs of a common cold
Flushing
* Cramps
Reporting Side Effects
If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Severe headache, neck stiffness, sensitivity to light, nausea, vomiting (signs of aseptic meningitis syndrome)
- Sudden pain, swelling, warmth, or discoloration in an arm or leg (signs of a blood clot)
- Shortness of breath, chest pain, rapid heart rate (signs of a blood clot in the lung)
- Decreased urination, sudden weight gain, swelling (signs of kidney problems)
- Unusual tiredness, pale skin, dark urine, yellowing of skin or eyes (signs of red blood cell breakdown)
- Hives, rash, itching, swelling of the face/throat, difficulty breathing, wheezing, dizziness (signs of a severe allergic reaction)
- Severe pain, swelling, or blistering at the injection site
Before Using This Medicine
It is essential to inform your doctor about the following conditions to ensure safe treatment:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced.
If you have IgA deficiency, a condition where your body lacks a specific antibody.
If you have hyperprolinemia, a condition characterized by elevated levels of proline in your blood.
If you have excess fluid in your body or have been advised to monitor your fluid intake.
* If you have low platelet levels, which can affect blood clotting.
This list is not exhaustive, and it is crucial to discuss all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. They will help you determine if it is safe to take this medication with your existing treatments and health conditions. Never start, stop, or adjust the dosage of any medication without consulting your doctor first.
Precautions & Cautions
Before receiving any vaccines, discuss the potential risks with your doctor, as certain vaccines may not be effective or may increase the risk of infection when taken with this medication.
Regular blood tests and other laboratory evaluations should be performed as directed by your doctor. Be aware that this medication may interfere with certain lab tests, so it is crucial to notify all your healthcare providers and laboratory personnel that you are taking this drug.
If you have a weakened immune system and have been exposed to measles, consult with your doctor to discuss the potential risks. This medication is derived from human plasma and, although it is thoroughly screened, tested, and treated to minimize the risk of infection, it may still pose a risk of transmitting viruses. Discuss this risk with your doctor.
Some products may contain maltose, which can affect the accuracy of certain glucose tests. Inaccurate glucose test results can lead to improper treatment of high or low blood sugar, potentially resulting in long-term consequences or even death. Consult with your doctor to determine the most suitable blood sugar tests to use.
If you are 65 years or older, exercise caution when taking this medication, as you may be more susceptible to side effects.
If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor to discuss the potential benefits and risks to you and your baby.
Overdose Information
Overdose Symptoms:
- Overdose is unlikely with subcutaneous administration due to slow absorption and catabolism. However, very large doses could potentially lead to fluid overload or hyperviscosity, especially in susceptible individuals.
What to Do:
Discontinue administration. Monitor vital signs and symptoms. Provide supportive care as needed. Contact a poison control center (e.g., 1-800-222-1222) or seek emergency medical attention.
Drug Interactions
Major Interactions
- Live virus vaccines (e.g., measles, mumps, rubella, varicella): May interfere with the immune response to these vaccines. Defer vaccination for at least 3 months after Hizentra administration. For measles, defer for 9 months.
Moderate Interactions
- Loop diuretics: While less common with SCIG than IVIG, caution is advised in patients receiving loop diuretics due to potential for increased risk of renal dysfunction, especially in predisposed individuals.
Monitoring
Baseline Monitoring
Rationale: To establish baseline and guide dose adjustments to achieve target therapeutic levels.
Timing: Before initiating therapy and periodically thereafter.
Rationale: To assess baseline renal status, especially in patients with pre-existing renal impairment or risk factors for acute renal dysfunction.
Timing: Before initiating therapy.
Rationale: To assess baseline hematologic status.
Timing: Before initiating therapy.
Rationale: To establish baseline for comparison during infusions.
Timing: Before first infusion.
Routine Monitoring
Frequency: Every 2-3 months initially, then every 6-12 months once stable, or as clinically indicated.
Target: Individualized, typically >800 mg/dL for PID; clinical response for CIDP.
Action Threshold: If levels are consistently below target or clinical response is inadequate, consider dose adjustment.
Frequency: Periodically, especially in patients with risk factors for renal dysfunction or those experiencing adverse events.
Target: Within normal limits for patient.
Action Threshold: Significant increase in BUN/creatinine warrants investigation and potential dose adjustment or discontinuation.
Frequency: During and after each infusion, and with patient self-monitoring.
Target: N/A
Action Threshold: Any severe or persistent reaction requires medical evaluation.
Frequency: Regularly, especially before and during infusions.
Target: Adequate hydration.
Action Threshold: Signs of dehydration require intervention.
Symptom Monitoring
- Infusion site reactions (pain, redness, swelling, itching, bruising)
- Headache
- Fatigue
- Fever, chills
- Nausea, vomiting, diarrhea
- Muscle or joint pain
- Rash, hives
- Signs of thrombosis (pain, swelling, discoloration of limb, shortness of breath, chest pain)
- Signs of aseptic meningitis syndrome (severe headache, neck stiffness, photophobia, nausea, vomiting, fever)
- Signs of renal dysfunction (decreased urine output, swelling, weight gain)
- Signs of hemolytic anemia (fatigue, pallor, dark urine, jaundice)
- Signs of allergic reaction (difficulty breathing, wheezing, swelling of face/throat, severe rash)
Special Patient Groups
Pregnancy
Hizentra is classified as Pregnancy Category C. Animal reproduction studies have not been conducted. However, immune globulins are known to cross the placental barrier, particularly in the third trimester. Clinical experience with immune globulin products suggests no harmful effects on the course of pregnancy, fetus, or neonate. Use only if clearly needed.
Trimester-Specific Risks:
Lactation
Human IgG is excreted into breast milk. The benefits of breastfeeding should be weighed against the potential risks. However, orally ingested immunoglobulins are generally considered safe for the infant as they are largely degraded in the infant's gastrointestinal tract and are not absorbed systemically in significant amounts. No adverse effects on the breastfed infant are expected.
Pediatric Use
Safety and efficacy for PID have been established in pediatric patients 2 years of age and older. Dosing is individualized based on body weight and clinical response. For CIDP, safety and efficacy have not been established in pediatric patients. Monitor for adverse reactions, especially infusion site reactions.
Geriatric Use
No specific dose adjustments are required based on age alone. However, elderly patients may have an increased risk of thrombosis or renal dysfunction, especially if pre-existing risk factors are present. Monitor renal function and hydration status closely.
Clinical Information
Clinical Pearls
- Hizentra is for subcutaneous use only; do NOT administer intravenously.
- Ensure proper training for self-administration, including aseptic technique and site rotation.
- Patients should be adequately hydrated before and during administration to minimize the risk of adverse events, particularly thrombosis.
- Infusion site reactions are common but usually mild and transient. Proper site rotation and slower infusion rates can help mitigate these.
- Patients should carry an emergency card or wear medical identification indicating their condition and treatment.
- Monitor for signs of aseptic meningitis syndrome, renal dysfunction, and thrombosis, especially in at-risk patients.
- Live virus vaccines should be deferred for several months after Hizentra administration due to potential interference with vaccine efficacy.
Alternative Therapies
- Other subcutaneous immune globulin (SCIG) products (e.g., Cuvitru, Gamunex-C, Gammaked, Xembify, HyQvia)
- Intravenous immune globulin (IVIG) products (e.g., Gammagard Liquid, Gamunex-C, Octagam, Privigen, Flebogamma)
- For CIDP, other treatments include corticosteroids, plasma exchange (PLEX), and other immunosuppressants.